2. What should I know before I am given ADRIAMYCIN?
You should not be given this medicine if you have ever had an allergic reaction to
ADRIAMYCIN or any of the ingredients listed at the end of the CMI or any other cancer
medication e.g. daunorubicin, epirubicin, mitozantrone.
You should not be given this medicine if you have a severe reduction in blood cell
count, severe heart disease, a severe infection or severe liver disease. Talk to your
doctor if you have any other medical conditions, take any other medicines, or are
pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with ADRIAMYCIN and affect how it works.
4. How is ADRIAMYCIN given?
ADRIAMYCIN is injected slowly into a vein or into the bladder. It must only be given
by a doctor or nurse. Your doctor will decide what dose, how often and how long you
will receive it. More instructions can be found in Section
4. How is ADRIAMYCIN given? in the full CMI.
5. What should I know while being given ADRIAMYCIN?
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Things you should do
|
Remind any doctor or dentist you visit that you are being given ADRIAMYCIN solution
for injection.
Tell your doctor immediately if you become pregnant while being treated with ADRIAMYCIN.
If you have the potential to fall pregnant, you must use effective contraception during
treatment and for at least 6 months and 10 days after your final dose. If you are
male and your partner has the potential to fall pregnant, you must use effective contraception
during your treatment and for 3 months and 10 days after your final dose.
Tell your doctor if you experience any signs of infection, such as sinusitis, tooth
abscess, sore red mouth, fever, sore throat, unusual bleeding or bruising, swollen
joints, nausea, vomiting, especially if it lasts for 24 to 48 hours.
|
|
Things you should not do
|
You should not be given this medicine if you are pregnant or you or your partner are
planning to become pregnant.
Do not breastfeed during treatment with ADRIAMYCIN and for at least 10 days after
your final dose.
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6. Are there any side effects?
Common side effects of this medicine may include: infection, heart problems, difficulty
in breathing, swelling of the feet, legs or stomach, unusual bruising or bleeding,
nausea, vomiting, diarrhoea or abdominal pain, sore throat or mouth ulcers, sores
in mouth and on lips, hair loss, darkening or redness of the skin, rash, fever, pain,
redness or pain where the injection is being given. Also, this medicine may colour
your urine red for 1-2 days after treatment.
Active ingredient(s): doxorubicin hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ADRIAMYCIN. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using ADRIAMYCIN.
Where to find information in this leaflet:
1. Why am I being given ADRIAMYCIN?
2. What should I know before I am given ADRIAMYCIN?
3. What if I am taking other medicines?
4. How is ADRIAMYCIN given?
5. What should I know while being given ADRIAMYCIN?
6. Are there any side effects?
7. Product details
1. Why am I being given ADRIAMYCIN?
ADRIAMYCIN contains the active ingredient doxorubicin hydrochloride and belongs to
a group of anticancer medicines known as cytotoxic anthracycline.
Doxorubicin hydrochloride works by preventing the growth of cancer cells and eventually
destroying them. It is used to treat different types of cancers including leukaemia,
soft tissue & bone sarcomas and cancers in breast, lymph nodes (Hodgkin's or Non-Hodgkin's),
lung, thyroid, liver, kidney, bladder or ovary.
2. What should I know before I am given ADRIAMYCIN?
Warnings
You should not be given ADRIAMYCIN if:
you have an allergy to doxorubicin or any of the ingredients listed at the end of
this leaflet
you are allergic to medicines from the same group (anthracyclines or anthracenediones)
(e.g. daunorubicin, epirubicin, idarubicin, mitozantrone or mitomycin C) or if you
have previously received the total permissible dose of doxorubicin or another medicine
from the anthracycline group
you have bone marrow suppression (reduced number of red or white blood cells or platelets)
caused by previous treatment with other cancer medicines or radiation therapy, symptoms
include tiredness, mouth ulcers or bleeding or bruising more easily than usual
you have heart disease or heart problems, have recently had a heart attack or experienced
chest pain or have a severe form of irregular heartbeats (arrhythmia)
you have a generalised infection
you have severe liver impairment
you have a tumour that has penetrated the bladder wall, a urinary infection, bladder
inflammation, a catheter in the bladder due to extremely large tumours or blood in
your urine)
if you are pregnant or breastfeeding
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
You should not be given this medicine if you or your partner are pregnant or planning
to become pregnant.
You are advised to avoid pregnancy during treatment as it may harm your developing
baby.
You are advised to seek doctor consultation on fertility preservation before treatment
with ADRIAMYCIN
Doxorubicin is known to pass into breast milk. Therefore, you should not breastfeed
while undergoing treatment and for at least 10 days after the last dose of ADRIAMYCIN.
Consult your doctor or midwife if you have any concerns about being unable to breastfeed
for this period.
Contraception
Women of childbearing potential should use effective contraception during treatment
with doxorubicin and for at least 6 months and 10 days after the final dose. Male
patients being treated with doxorubicin must use effective contraception during treatment
and for at least 3 months and 10 days after the final dose if your partner is of childbearing
potential. You should seek advice on fertility preservation before treatment.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and doxorubicin may interfere with each other. These include:
other cancer medicines, such as cyclophosphamide monohydrate, paclitaxel, 6-mercaptopurine,
sorafenib
some medicines used to prevent blood clots, such as heparin
propranolol and other medicines for your heart.
verapamil used for high blood pressure, angina or irregular heartbeat
phenobarbital and phenytoin used to treat epilepsy
St. John's Wort, a herbal supplement, used for mild anxiety and low mood
ciclosporin used in transplant patients to prevent organ rejection.
These medicines may be affected by ADRIAMYCIN or may affect how well it works. You
may need different amounts of your medicine, or you may need to take different medicines.
Your doctor will advise you.
ADRIAMYCIN given at the same time as radiation therapy may also cause unwanted effects.
Your doctor has more information on medicines to be careful with or avoid while using
ADRIAMYCIN.
Avoid vaccination with certain vaccines. Your doctor or pharmacist will tell you what
vaccines to avoid.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ADRIAMYCIN.
4. How is ADRIAMYCIN given?
How much and how long is it given
You should only be treated with ADRIAMYCIN by a doctor who is experienced in treating
patients with cancer. Treatment will normally take place in a hospital because of
the need for hospital facilities and healthcare professionals.
ADRIAMYCIN is given in a clinical setting by a nurse or doctor.
You will be given a blood test, and your heart will be monitored before you start
treatment with ADRIAMYCIN.
Your doctor will decide what dose, how often and how long you will receive it. This
depends on your condition and other factors, such as your weight, liver function and
the effect on your bone marrow of any previous treatment you may have had with x-ray
or other medicines are being given at the same time.
ADRIAMYCIN is given by slow infusion into a vein or the bladder. If it is infused
into the bladder, you will be asked not to urinate for one hour while ADRIAMYCIN is
given.
Treatment is usually given once every 3 weeks, or on 3 successive days repeated every
4 weeks. However, your doctor may give ADRIAMYCIN more or less frequently.
Your doctor will monitor the effects of ADRIAMYCIN on your blood, liver and heart
regularly by giving you tests.
Tell your doctor or nurse immediately if stinging, burning or pain develops at the
injection site.
Ask your doctor if you have any questions about the dose of ADRIAMYCIN and how it
is given.
If too much ADRIAMYCIN is given
Since ADRIAMYCIN is given in a hospital or clinic under the supervision of a doctor,
it is very unlikely that you will be given too much of the medicine. Your doctor or
nurse will be monitoring your progress and checking the medicine that you are given.
If you think that you have been given too much ADRIAMYCIN, you may need urgent medical
attention.
Immediately tell your doctor or telephone the Poisons Information Centre (Phone 13
11 26) for advice or go to Accident and Emergency at your nearest hospital if you
have side effects after being given ADRIAMYCIN.
5. What should I know while being given ADRIAMYCIN?
Things you should do
Keep all your doctor's appointments.
You will need regular follow-up to check your progress.
You will also have blood tests and heart monitoring to check for side effects.
Tell your doctor immediately if you become pregnant while being treated with ADRIAMYCIN.
Call your doctor straight away if you experience any of the following during or after
treatment:
stinging, burning or pain develops at the injection site
any signs of infection, such as sinusitis, tooth abscess, sore red mouth, fever, sore
throat
unusual bleeding or bruising
gout, a disease with painful, swollen joints
nausea, vomiting, especially if it lasts for 24 to 48 hours.
Treatment with doxorubicin can cause bone marrow damage, which can result in infections
and/or severe bleeding. Your doctor will closely monitor your blood cell levels to
be able to respond quickly and start treatment if these conditions occur.
Take the following precautions to reduce your risk of infection or bleeding:
Avoid people who have infections. Check with your doctor immediately if you think
you may be getting an infection, or if you get a fever, chills, cough, hoarse throat,
lower back or side pain or find it painful or difficult to urinate
Be careful when using a toothbrush, toothpick or dental floss. Your doctor, dentist,
nurse or pharmacist may recommend other ways to clean your teeth and gums. Check with
your doctor before having any dental work
Be careful not to cut yourself when you are using sharp objects such as a razor or
nail clippers
Avoid contact sports or other situations where you may bruise or get injured.
Avoid vaccination with certain vaccines. Your doctor or pharmacist will tell you what
vaccines to avoid.
Tell your doctor if you are having or have had radiotherapy.
Tell your doctor if you are having or have had treatment with other anticancer medicines.
Tell your doctor if you have liver problems or kidney problems.
You should not be given this medicine if you have severe liver problems. Your doctor
may need to monitor your liver or kidney function and adjust the doxorubicin dose
if necessary.
Tell your doctor if you have or have had heart disease or have high blood pressure.
Tell any doctors, dentists or pharmacists who treat you that you are being treated
with ADRIAMYCIN.
Women of childbearing potential should use effective contraception during treatment
and for at least 6 months and 10 days after the final dose. Male patients being treated
must use effective contraception during treatment and for at least 3 months and 10
days after the final dose if your partner is of childbearing potential.
Women should not breastfeed while undergoing treatment and for at least 10 days after
the last dose of Adriamycin. Consult your doctor or midwife if you have any concerns
about being unable to breastfeed for this period.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ADRIAMYCIN
affects you.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ADRIAMYCIN contains
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Active ingredient
(main ingredient)
|
Doxorubicin hydrochloride
|
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Other ingredients
(inactive ingredients)
|
Hydrochloric acid
Sodium chloride
Water for injection
|
Do not take this medicine if you are allergic to any of these ingredients.
What ADRIAMYCIN looks like
ADRIAMYCIN is a clear red solution in a clear vial.
Australian Registration Numbers
10 mg/5 mL: AUST R 15407 (not currently supplied)
20 mg/10 mL: AUST R 47344 (not currently supplied)
50 mg/25 mL: AUST R 47345
200 mg/100 mL: AUST R 47345
Who distributes ADRIAMYCIN
Pfizer Australia Pty Ltd
SYDNEY, NSW.
Toll Free Number: 1800 675 229.
This leaflet was prepared in September 2025